A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

NCT00623428 | Completed Phase 3 Results

• 2 other identifiers: MV213712007-004993-15
• Study Type: interventional
• Target: 235
• Locations: 9 countries
• Sites: 96

Brief Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment

  Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.

  24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.

• Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment

  Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.

  24 weeks after actual end of treatment (range from Week 48 to Week 72).

Secondary Outcomes (5)

• Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation

  Week 72

• Percentage of Participants With Virological Response at End of Treatment

  End of Treatment (Week 24 and Week 48 for each treatment group respectively).

• Percentage of Participants With Virological Relapse

  End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).

• Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment

  12 weeks after actual end of treatment (range from Week 36 to Week 60)

• Number of Participants With Adverse Events (AEs)

  From Week 1 through Week 72.

Study Arms (2)

PEG-IFN alfa-2a + Ribavirin for 24 weeks

EXPERIMENTAL

After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.

Drug: peginterferon alfa-2a; Drug: Ribavirin

PEG-IFN alfa-2a + Ribavirin for 48 weeks

ACTIVE COMPARATOR

After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.

Drug: peginterferon alfa-2a; Drug: Ribavirin

Interventions

peginterferon alfa-2a DRUG

Also known as: Pegasys®, PEG-IFN alfa-2a

PEG-IFN alfa-2a + Ribavirin for 24 weeks; PEG-IFN alfa-2a + Ribavirin for 48 weeks

Ribavirin DRUG

Also known as: Copegus®

PEG-IFN alfa-2a + Ribavirin for 24 weeks; PEG-IFN alfa-2a + Ribavirin for 48 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• serological evidence of chronic hepatitis C (CHC);
• CHC genotype 2 or 3;
• receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
• compensated liver disease.

You may not qualify if:

• pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
• coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
• history or other evidence of decompensated liver disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (101)

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Birmingham, Alabama, 35294, United States

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La Jolla, California, 92037-1030, United States

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Lancaster, California, 93534, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90057, United States

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Sacramento, California, 95816, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92103-8465, United States

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Torrance, California, 90505, United States

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Aurora, Colorado, 80045, United States

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Jacksonville, Florida, 32256, United States

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Orlando, Florida, 32803, United States

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Atlanta, Georgia, 30308, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96813, United States

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Baton Rouge, Louisiana, 70890, United States

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Opelousas, Louisiana, 70520, United States

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Boston, Massachusetts, 02114, United States

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Tupelo, Mississippi, 38801, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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Egg Harbour Township, New Jersey, 08234, United States

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Hackensack, New Jersey, 07601, United States

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Albuquerque, New Mexico, 87131, United States

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New York, New York, 10016, United States

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Syracuse, New York, 13210, United States

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Asheville, North Carolina, 28801, United States

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Chapel Hill, North Carolina, 27599-7080, United States

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Winston-Salem, North Carolina, 27103, United States

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Oklahoma City, Oklahoma, 73112-4481, United States

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Portland, Oregon, 97239, United States

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Kingsport, Tennessee, 37660, United States

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Fort Sam Houston, Texas, 78234-3879, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Fairfax, Virginia, 22031, United States

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Richmond, Virginia, 23249, United States

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Darlinghurst, 2010, Australia

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Fremantle, 6160, Australia

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Melbourne, 3186, Australia

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Nedlands, 6009, Australia

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Sydney, 2139, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Oberndorf, 5110, Austria

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Vienna, 1090, Austria

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Vienna, 1160, Austria

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Antwerp, 2650, Belgium

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Brussels, 1000, Belgium

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Brussels, 1020, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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Liège, 4000, Belgium

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Brasília, 70335-000, Brazil

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Campinas, 13012-970, Brazil

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Campinas, 13081-970, Brazil

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Porto Alegre, 90020-090, Brazil

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Porto Alegre, 90035-003, Brazil

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Ribeirão Preto, 14049-900, Brazil

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Rio de Janeiro, 20020-022, Brazil

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Santo André, 09060-650, Brazil

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São Luís, 78048-790, Brazil

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São Paulo, 04040-003, Brazil

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Sorocaba, 18047-600, Brazil

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Vitória, 29043-260, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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Mississauga, Ontario, L5M 4N4, Canada

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Berlin, 10969, Germany

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Berlin, 13353, Germany

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Bonn, 53127, Germany

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Cologne, 50937, Germany

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Düsseldorf, 40225, Germany

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Düsseldorf, 40237, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Giessen, 35392, Germany

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Hamburg, 20099, Germany

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Heidelberg, 69120, Germany

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Jena, 07747, Germany

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Kiel, 24105, Germany

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Mainz, 55101, Germany

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München, 81675, Germany

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Offenburg, 77654, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Guadalajara, 44160, Mexico

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Guadalajara, 44670, Mexico

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Mexicali, 21000, Mexico

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Mexico City, 11649, Mexico

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Mexico City, 14050, Mexico

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Puebla City, 72560, Mexico

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Santurce, 00909, Puerto Rico

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Lausanne, 1005, Switzerland

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Lugano, 6903, Switzerland

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Sankt Gallen, 9007, Switzerland

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Zurich, 8091, Switzerland

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MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 26, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 22, 2013
• Results First Posted: June 24, 2013

Record last verified: 2013-07

Locations

DE (18); ME (6); CA (4); US (38); AU (6); BE (7); PR (1); CH (4); BR (12)